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Islet Cell Transplants for Diabetes

NCT00303134 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-06-03

No results posted yet for this study

Summary

The purpose of this study is to test the safety and efficacy of islet cell transplants for the treatment of type 1 diabetes mellitus. It has been shown that normal control of blood sugar levels can prevent progression of complications (such as kidney disease, nerve damage, and vascular disease) from diabetes. This research study is designed to see if normal blood sugar control can be achieved by transplanting pancreatic islet cells into your liver, which may reduce or eliminate your need for insulin. Patients may qualify to participate in this research study if they have type 1 diabetes mellitus for at least five years and meet at least one of the following criteria:

* Experience hypoglycemic unawareness - Defined as inability to tell when blood glucose is low (for example, may not feel symptoms such as shaking, sweating, and rapid heartbeat that usually signify that glucose is low)
* Have been hospitalized several times in the past year for low blood sugar and/or high blood sugar
* Have complications of diabetes such as retinopathy, kidney problems, or neuropathy

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Islet Cell Transplantation

Islet Cell Transplantation for patients with type 1 diabetes mellitus

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Meredith J Aull, Pharm.D. · New York Presbyterian Hospital - Weill Cornell Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-01
Primary Completion
2007-10-23
Completion
2010-06-24

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00303134 on ClinicalTrials.gov